Ethics committees and research papers, a match made in practice
The relationship between an ethics committee and ethical research is intrinsic. Emre Ilhan and Cathy Said, who sit on university and hospital ethics committees respectively, share their insights.
What is your background as a physiotherapist?
EMRE My main areas of clinical work are in acute adult and paediatric care. I am also completing a PhD in neonatal and infant pain and work as a lecturer at Macquarie University.
CATHY I have spent most of my career in the public hospital system, predominantly in neurological and aged care rehabilitation. I have a joint appointment between the University of Melbourne and Western Health, where I support the development of research activity within the Physiotherapy Department at Western Health.
What is the role of an ethics committee and why is this important to the research process?
EMRE I am member of a Human Research Ethics Committee (HREC). HRECs ethically oversee research involving humans. Our role is to review research proposals that include humans so that they are ethically acceptable and that they comply with national standards and guidelines. The review of research by HRECs ensures that research is conducted safely, and that investigators are aware of and minimise any risks associated with conducting their research.
CATHY The role of the ethics committee is to review proposed research and ensure it complies with the National Statement on Ethical Conduct in Human Research (NHMRC). The ethics committee plays a crucial role in the research process; it ensures that the proposed research treats potential participants in an appropriate and respectful manner, that the research is methodologically sound and that it is conducted in a manner that balances potential risks and benefits. The ethics committee also ensures that the research complies with any relevant state and national laws.
How much work is involved?
EMRE We come together monthly to present our review of ethics applications. Before we meet we are given time to review each application—to reach a final decision everybody’s contribution is needed; however, ethics applications are assigned to individuals in the committee who act as primary and secondary reviewers.
CATHY The amount of work varies depending on how many applications your committee receives, how frequently the committee meets and how many people are on the committee. In the last month I spent around two hours of work for the committee; however, some months this can be much more.
What is your contribution as a physio? Does this match your expectations going into the role?
EMRE My knowledge as a physiotherapist has been paramount when reviewing ethics applications. A lot of applications that we receive involve clinical research, which means I rely on my clinical experience and training to evaluate whether a research proposal is ethically acceptable. I also think that appraising the ethical aspects of research also requires me to see the research being proposed from the participants’ point of view, as they are ones who we’re trying to protect when reviewing ethics applications.
CATHY I don’t specifically sit on the committee as a ‘physio’; rather, I sit on the committee as a clinical researcher. However, I think my background as a physio gives me specific expertise when reviewing studies that have complex interventions, or studies that are conducted in busy clinical environments.
How are you challenged in your role?
EMRE Often, we receive applications that are outside of my scope of practice and knowledge such as those relating to genomics, for instance. Given investigators must write their applications that are understandable to laypeople, specific knowledge is not a prerequisite to review an application. That being said, sometimes further reading has helped me to anticipate any ethical considerations that I may not have previously thought about.
This has required me to learn more about other speciality areas, but in particular, the ethical considerations of these areas. Several journals and websites are dedicated to discussing ethical issues that are pertinent to specific research topics. Learning more about other areas has greatly benefited my clinical work and research.
CATHY I review applications from all areas; sometimes applications that are in an area that are not within my area of expertise are difficult to review. One of the things I have learnt is that a good application can be understood by anyone who sits on the committee; not just someone who is familiar with your area.
Is there scope for more physios to join? What type of physio should consider joining an ethics committee?
EMRE Absolutely, any physiotherapist who does clinical or research work with humans—or even those who are simply interested in research ethics should definitely join.
CATHY Ethics committees will usually put out a call when they require new members. Physiotherapists who have experience in research and are interested in developing a research career should consider joining.
Is there a connection between the role of an ethics committee and the conducting of a valuable research project? If so, what is the relationship between the two?
EMRE While HRECs are responsible for ensuring research projects are conducted ethically, Scientific Advisory Committees (SACs) can be utilised to ensure that projects have a high level of scientific rigour. Many times, HRECs and SACs work together. That being said, members of HRECs are very cognisant that research being done poorly has the potential to be unethical. This is because they may produce uncertain findings on the basis of poor methodology and thus result in the waste of resources, participant time, money, increase the risks associated with incorrectly executed assessments and treatments of vulnerable patient populations, and so on.
It should be noted that, in addition to careful scrutiny by a SAC, members of a HREC tend to be experts in their own fields such as medicine, psychology, sociology, bioethics, and of course, physiotherapy. A high level of review is also provided by the fact that a HREC is made up of a diverse group of individuals including laypeople, clinicians, those involved in pastoral care, lawyers, and researchers. In this way, the feedback provided to investigators during an ethics review ensures that research is not only valuable to society but is conducted in a robust manner.
CATHY When you submit a manuscript for publication you will normally need to indicate whether you had ethics approval; journals will not publish any manuscript that contains information on human participants without ethics approval. So, you don’t need ethics approval to do a systematic review. There is usually an ongoing relationship between the ethics committee and researchers, the ethics committee normally requires reports on an annual basis— and you also need to report any ‘adverse events’ that may occur.
Ethics committees also review any changes to the protocol that you may need to make. In my experience, at the initial review stage ethics committees will sometimes provide feedback to researchers about ways to improve the methodological rigour of studies. The reviewers want to help researchers conduct research that will be worthwhile, answer their proposed question, be of interest to other researchers and clinicians, and be published.
>> Emre Ilhan is a lecturer at Macquarie University and physiotherapist working with the adult and paediatric population. Emre’s PhD aims to define non-acute pain in babies admitted to the neonatal intensive care unit and assess its impact on short-term and long-term outcomes such as neurodevelopment, psychological wellbeing, and growth.
>> Cathy Said, the inaugural Associate Professor Physiotherapy, Western Health and The University of Melbourne, has been working in neurological and aged care rehab for over 25 years. Her research focuses on rehab of gait and balance disorders in older people with complex health conditions and people with neurological disorders. Cathy is chair of the PRF Grants Review Committee.
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